To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese

Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Study ID
NCT06396429
Phase
PHASE3
Status
Completed

Conditions

  • Overweight or Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HRS9531 injection — DRUG
    HRS9531 injection; low dose
  • HRS9531 injection — DRUG
    HRS9531 injection; medium dose
  • HRS9531 injection — DRUG
    HRS9531 injection, high dose
  • Placebo — DRUG
    blank preparation, participants received matching placebo.

Study Details

The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 weeks.

Key Dates

Start date
May 13, 2024
Status verified
Jul 2025
Primary completion
Jul 7, 2025
Completion
Jul 7, 2025

Study Design

Enrollment
567 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A: HRS9531 injection
  • Experimental: Treatment group B: HRS9531 injection
  • Experimental: Treatment group C: HRS9531 injection
  • Placebo Comparator: Placebo injection

Primary Outcome Measure

Percentage change from baseline in weight after 48 weeks of treatment [ Time Frame: Baseline, Week 48 ]

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